Section III - Factor VIII/IX: Clinical issues- II (Outcomes / Inhibitors)
Chairmen: Charles Hay (UK) and Kathelijn Fischer (NL)  

Overview
Charles Hay (UK) and Kathelijn Fischer (NL) 5 min

09:00

Definitions in hemophilia – Report of the working party. 
Victor Blanchette (CA) 20 min

09:05

Pharmacokinetic evaluation in hemophilia – Report of the working party. 
Sven Bjorkman (SE), Peter Collins (UK)

09:25

International ITI study: Update. 
Donna DiMichele (US)  / Charles Hay (UK)

09:45

Genetic predictors of inhibitor development – Update of ongoing studies. 
Jan Astermark (SE)

10:00

Regulatory perspective  on clinical development of FVIII/FIX concentrates – FDA.
Nisha Jain (US)

10:15

EU-Regulatory perspective on clinical development of FVIII/FIX concentrates - EMEA.
Anneliese Hilger (DE)

10:30

General discussion / Future directions.

10:45

Coffee break

Section IV - Factor VIII/IX: Products and Standards
Chairmen: Johannes Oldenburg (DE) and Leonard Valentino (US)

Overview 
Johannes Oldenburg (DE) and Leonard Valentino (US)

11:00

New factor concentrates – ‘Biosimilars’or ‘Biosuperiors’: How do we evaluate them for clinical use? 
Leonard Valentino (US)

11:05

Evaluating new factor concentrates – What are the issues?
Martin Lee (US)

11:20

Evaluating new factor concentrates – Regulatory perspectives: EMEA.
Anneliese Hilger (DE)

11:35

Evaluating new factor concentrates – Regulatory perspectives: FDA.
Mark Weinstein (US)

11:50

Review of completed and new standardization projects on standards. 
Anthony Hubbard (UK)

12:05

4^th International Standard for Blood coagulation Factors II, VII, IX and X, Plasma. 
Elaine Gray (UK)

12:15

Factor VIII inhibitor standard: Status update. 
Koen Mertens (NL)

12:25

FVIII field study – Comparison of BDD product with a full length product. 
David Lillicrap (CA)

12:35

General discussion / Future directions.

12:45

Closing remarks 
Alok Srivastava (IN)

12:55

Part 1: Fibrinogen

An update on the replacement of the 2nd International Standard for Fibrinogen, Plasma (98/612)

Sanj Raut (UK)

9:00

An update on the replacement of the 1st International Standard for Fibrinogen, Concentrate(98/614)

Sanj Raut (UK)

9:15

Polyphosphate modifies the fibrin network and down-regulates fibrinolysis by attenuating binding of t-PA and plasminogen to fibrin

Nicola J Mutch (UK)

9:30

Update on fibrin structure standardization 
Marlien Pieters (ZA)

09:55

Molecular mechanisms of fibrin-VE-cadherin interaction and anti-inflammatory properties of fibrin-derived peptides

Leonid Medved, Sergiy Yakovlev, Li Zhang (USA)

10:20

Coffee break

10:40

Part 2: Factor XIII

Challenges of assigning a FXIII-B value to the 1st international FXIII standard plasma; scientific and methodological considerations

Muszbek L, Katona É and Bagoly Z (HU)

11:00

Project of a pilot study to establish the normal value of F13-B concentration using the international standard plasma

Akitada Ichinose (JP)

11:20

International survey of acquired hemophilia 13 (Hemorrhagic acquired factor 13 deficiency). Proposal for a future international collaborative study

Akitada Ichinose (JP)

11:40

Association of FXIII-A with Golgi proteins within monocyte-macrophages

Paul Cordell (UK)

12:00

Does MBL-associated serine protease 1 (MASP-1) of the complement system activate factor XIII and induce fibrin formation?

Verena Schroeder (UK)

12:20

Pharmacokinetics of recombinant factor XIII-A2 administration in patients with congenital factor XIII deficiency

Diane J Nugent (US)

12:40

Preclinical and Translational studies

Chairmen:  Wolfram Ruf (US) and Marina Marchetti (IT)

Tissue factor and intracellular signaling in cancer-associated thrombosis: updates and future direction
Wolfram Ruf (US)

09:00

Tissue factor microparticles: roles and relevance in cancer-associated thrombosis
Jeffrey Zwicker (US)

09:30

Tissue factor standardization: update of SSC activity
Marina Marchetti (IT)

10:00

Coffee break

10:30

Clinical Cohorts, Trials and Registries
Chairmen:  Alok A Khorana (US) and Dominique Farge (FR)

Prophylaxis in outpatients – time for action?
Alok A Khorana (US)

11:00

Prophylaxis in MM – how strong is the evidence?

Marc Carrier (CA)

11:30

Incidental thrombosis – to treat or not to treat?
Howard Liebman (US)

12:00

Ongoing Studies and New Proposals
Chairmen:  Agnes Lee (CA), Martin Prins (NL)

Updates on INPACT, VTE treatment, and others

Martin Prins (NL)

12:30

European guidelines for VTE management in cancer

Dominique Farge-Bancel (FR)

12:45

Introduction

Paul Monagle (AU)

9:00

Improving anticoagulant trials in children
Chairmen:  Gili Kenet (IL), Ulrike Nowak-Gottl (DE)

From adults to neonates: Proposing a standard approach to introducing new anticoagulant drugs in children.
Guy Young (US), Christoph Male (AT)

09:15

Safety and efficacy endpoints in paediatric anticoagulant trials: Developing an ISTH position paper
Lesley Mitchell (CA)

09:35

PTS as an outcome measure of paediatric thrombosis therapy: can we develop standardised criteria?
Anthony Chan (CA)

09:55

Quality of life as outcome measure for anticoagulant trials in children: Developing a standardised tool
Patti Massicotte (CA)

10:15

Laboratory monitoring of anticoagulants in children: developing a uniform approach

Paul Monagle (AU)

10:35

Diagnostic criteria for thrombosis in children: Which radiological techniques are validated?
Leo Brandau

10:55

Coffee break

11:15

Interpretation of laboratory tests in children and clinical bleeding

Chairmen: Anthony Chan (CA), Christoph Male (AT)

Developmental Haemostasis : Recommendations for laboratories reporting paediatric samples

Gili Kenet (IL)

11:30

Role of thrombophilia testing in children: development of standard indications for testing and assay methodologies

Ulrike Nowak-Gottl (DE)

11:50

Laboratory assessment of bleeding disorders in children: Standardisation protocols

Nicole Schlegel (FR)

12:10

Seven Bleep Registry update
Jan Blatny (CZ), Prasad Mathew (US)

12:30

Concluding remarks

Paul Monagle (AU)

12:50

Welcome note

09:00

Role of factor XII in thrombus formation on collagen.
Paola van der Meijden (NL)

09:05

Activated factor XII as a risk predictor for cardiovascular disease?
Dennis Nielson (NO)

09:30

The plasma Kallikrein-Kinin system and regulation of endothelial progenitor cell function.
Yi Wu (US)

09:55

Diagnosis and treatment of hereditary angioedema – in 2010.
Marco Chicardi (IT)

10:20

Presentation of the C1 inhibitor standard.
Craig Thelwell (UK)

10:45

Coffee break

Role of Factor XII in lung fibrosis.
Klaus T. Preissner (DE)

11:15

Factor XI activation in vivo.
Henri Spronk (NL)

11:40

Plasma kallikrein/factor XI structure function relations.

Jonas Emsley (UK)

12:05

Polyphosphates, novel procoagulant activators.

Nicola Mutch (UK)

12:30

Concluding remarks, general discussion points

12:55

Welcome Andreas Greinacher (DE)

Autoimmune thrombocytopenia 
Chairman: Donald Arnold (CA)

Platelet antibody testing in ITP: The need for standardization 
Donald Arnold (CA)

09:05

Are GPIIbIIIa and GPIbIX glykoproteins sufficient for platelet autoantibody testing?
Hartmut Kroll (DE)

09:30

Round table discussion on platelet antibody standardization workshop. Focus on application of platelet antibody tests to clinical studies.

Discussion topics

• The need for direct and indirect testing
• Sample procurement/ anticoagulant
• How to prepare shared samples for direct testing (fresh vs. frozen, volume of collection)
• What antigenic target(s)

09:45

Alloimmune thrombocytopenia
Chairman: Hartmut Kroll (DE)

Update on platelet alloantigen systems: New approaches in antigen/antibody detection
Sentot Santoso (DE)

10:15

Low affinity platelet alloantibodies, detection and its relevance 
Sentot Santoso (DE)

10:30

Prediction of NAIT

B. Skogen (NO)

10:45

Genetic pitfalls in platelet genotyping and new platelet antigen(s).

G. Bertrand, V. Jallu, Cécile Kaplan (FR)

11:00

Antenatal management of 81 high risk pregnancies: Maternal immunization and consideration for a less invasive strategy.

G. Bertand and Cécile Kaplan (FR) for the French working group

11:15

Which of the new aspects should be considered for diagnostic approaches and treatment in neonatal alloimmune-thrombocytopenia?

Hartmut Kroll (DE)

11:30

Coffee break

11:45

Heparin-induced thrombocytopenia

Chairmen: Yves Gruel (FR), Andreas Greinacher (DE)

How to improve the clinical use of antigen assays in HIT

Thrombin generation potential in HIT. Does it correlate with clinical manifestation?
B. Tardy

12:00

Toward standardization of anti-PF4/heparin antigen assays
Andreas Greinacher (DE)

12:15

PF4/polyanion complexes: are there other implications?
K. Krauel (DE)

12:30

New data on the performance of PF4/heparin antibody assays.

12:45

Last minute contributions of the participants are welcome. Contributions MUST not be longer than 8 min and should be declared to the chairman at the latest 5 days before the meeting.